TIJUANA,
Mexico: Maggie Alejos arrived here in June from St Anne, Ill, with her
husband, her daughter and a cashier's check for $13,500, payable to the
Regenerative Medicine Institute.
Rail-thin, with an oxygen
tube anchored above her upper lip, Alejos, a retired army nurse, has
coped with emphysema for a dozen of her 65 years. Once she came close
enough to a lung transplant that doctors prepared her for surgery, only
to discover that the donor lung was unfit.
At a hospital here,
doctors affiliated with the institute extracted about seven ounces of
fat from her thighs, hoping to harvest about 130 million stem cells and
implant them in her failing lungs.
Across the internet — where Alejos learned about the Tijuana institute —
adult stem cells are promoted as a cure for everything from sagging skin to severed spinal cords.
On the surface, the claim is plausible. Scientists have discovered that
fat, bone marrow and other parts of the body contain stem cells,
immature cells that can rejuvenate themselves — at least in the tissue
they are naturally found.
But it has yet to be proved that
these cells can regenerate no matter where they are placed, or under
what conditions this might occur. Moreover, questions about safety
remain unanswered.
These sober realities do not appear to have
slowed the rise of an international industry catering to customers who
may pay tens of thousands of dollars in cash for their shot at a
personal miracle. (Some foreign operators offer creative variations on
the theme, like cells from sharks and sheep.)
Domestic
providers, too, can push the limits. In July, for example, a former
pathologist at the Medical University of South Carolina pleaded guilty
to illegally processing and shipping stem cells for treatment without
approval from the university or the Food and Drug Administration.
The number of clinics and products has reached the point that
scientists fear repercussions for their own work. Dr Hesham Sadek of the
University of Texas Southwestern Medical Center in Dallas, who is
studying heart muscle regeneration, worries that the marketing deluge
now makes it hard for patients to tell science from swindle, and all
that lies on the spectrum in between.
"It really has the potential to undermine the legitimacy of the whole field," he said.
Even though Tijuana has perhaps 20 clinics offering
adult stem cell therapy,
Dr Javier Lopez, founder of the Regenerative Medicine Institute, says
it is his that has become "the poster company to knock down".
Born and educated in Tijuana, he has lived and worked across the border,
in San Diego, for more than 30 years, mainly as a health care
administrator. He became inspired by stem cells after accompanying a
physician friend to a conference in Palm Springs, Calif., in 2008.
"It was eye-opening," he said. "I immediately thought, 'This is the future of medicine, and I want to be a part of it.'"
He says he runs the institute within the accepted framework of clinical
trials: Patients sign consent forms acknowledging that the treatment is
experimental. Studies are registered with the National Library of
Medicine in the United States.
Being accepted for treatment
requires more than cash. Protocols and procedures are approved by the
institutional review board, or IRB, at Hospital Angeles Tijuana, and are
administered by physicians at the hospital. "The focus of our trial,
from Day 1, has been safety," Lopez said.
Still, sceptics in
the United States are not convinced. Leigh Turner, a bioethicist at the
University of Minnesota, says the Regenerative Medicine Institute blurs
the boundary between trial and treatment.
The institute's
patient consent form "would not pass muster with a competent American
IRB", Turner said, and the testimonials on its website place the
emphasis squarely on results.
Moreover, studying patients who
pay undermines the trials' scientific validity, Turner said. The patient
sample is skewed toward those with the means to travel, and their
financial investment may amplify an already strong placebo effect.
Lopez says that scientists in Mexico lack the government research
support available in the United States, leaving establishments like his
no choice but to charge patients.
He agrees that many stem cell
providers are dubious, and says he works with the Mexican authorities
to try to establish uniform standards. As for his own institute, he
said, "I'm very proud of what we are doing," and added, "I get upset
when people start talking trash about what is done south of the border."
A grey area In the United States,
too, it is easy to conduct business outside government oversight, said
Dr George Q Daley, who studies stem cells for blood diseases at Harvard
Medical School. Close down one shady operation, he went on, and more
seem to randomly pop up.
Even questionable publicity does not
necessarily hurt business. Regnocyte, a company in Florida, posted an
unflattering CNN report about it on its website under the heading
"special coverage."
If the stem cell business continues to
flourish without proper scrutiny, Daley and others fear research
progress will suffer. Clinical trials depend on patients who are willing
to sign on even though they know they might be given a placebo, while
competing clinics are offering what seems to be a sure thing. In
addition, patients who have already had stem cell therapy could be
ineligible for trials.
And if too many patients try stem cells
unsuccessfully, the public may come to see the entire field as a
failure, said Sadek, the heart cell scientist in Dallas. Many comments
on articles about his last paper, published in the journal Nature, "were
sceptical and jaded", he continued. "One said, 'I've gotten stem cell
therapy and nothing happened.' If the public loses faith in regenerative
medicine in general, funding can be affected."
A lack of data
Beyond the online testimonials, there is little evidence to indicate
whether adult stem cell treatments on offer are working. Paul Knoepfler,
a stem cell researcher at the University of California, Davis, says the
lack of data is vexing.
"There is absolutely no legitimate
reason for such clinics to be not publishing their data," he wrote on
his stem cell blog this year. "Yet they almost never do it."
Stem cell businesses say they have other priorities. "I'm not that
interested in doing a lot of research for publication purposes only,"
said Maynard A Howe, the chief executive of Stemedica Cell Technologies
in San Diego, which is developing a drug made from donated stem cells.
Howe and his brother Roger started the company in 2005 after a
sister-in-law received stem cells in Russia for a spinal cord injury.
Howe says that his company publishes just enough data to meet FDA
requirements, but that he would rather his scientists spend their time
getting a product to market.
He also defends the practice of
foreign trials largely on economic grounds. Outside the United States,
he said, "I can do a PET scan for $500," a fraction of the typical
American rate. "Why wouldn't I do my clinical trial overseas?"
For his part, Lopez says he is trying to publish data from the 125
patients he has treated so far, but he faces a struggle. "Nobody wants
to talk to us because we are from Tijuana," he said of medical journals.
He has managed to get just a case description accepted for publication.
So for now, he does not have much to show in the way of
science. He believes in stem cells — and in that, he and his critics
share common ground. The challenge for scientists is to promote the
promise of stem cells with both excitement and restraint. It can be a
hard line to walk.
"I understand how difficult it is — how many
years and sometimes decades it takes before you discover a new
therapy," said Daley, of Harvard. "We have a
tremendous enthusiasm about the potential of stem cell therapy."
"That said, these aren't magical agents that run around your body and
fix things. It's frustrating to watch other people who, even well
intentioned, aren't acting in their patients' best interest."
This week, the International Society for Stem Cell Research is to
release a statement declaring the use of stem cells outside scientific
settings to be "a threat to patient welfare, patient autonomy and to the
scientific process," according to its public policy chairman, Jonathan
Kimmelman, a bioethicist at McGill.
This is the same group that
once tried to offer an online guide to stem cell clinics, but the
journal Nature reported that the effort was abruptly abandoned under
threat of lawsuits.
Alejos says she accepts the uncertainty of
her choice. She came to Tijuana because nothing else had worked. After
her anticipated lung transplant fell through, she turned to Google and
found stem cell doctors throughout Asia and Latin America who were
willing to treat her. Close to home, Mexico felt comfortable.
She was well aware of the controversy over stem cell tourism. Even most of her family did not know where she was headed.
Back home in St Anne a few days after the procedure, she had a brief
bout of pneumonia over the summer, but generally feels no better or
worse than she did before her treatment. She knows she will not be
cured. Her dreams are modest, like being untethered from oxygen long
enough to go out to a movie.
"I was an army nurse for 30 years," Alejos said. "I know there is no such thing as a miracle in the world of medicine."
